A Prospective Study of Treating Duodenal Papillary Sphincter in Different Ways During ERCP

ERCP Clinical Trial

Official title:

A Prospective Study of Treating Duodenal Papillary Sphincter in Different Ways During ERCP: Comparison of EST, EPBD, and sEST+EPBD in Endoscopic Choledocholithiasis Treatment.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03416205
• Other study ID #: 2017-XHNK-001
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 15, 2017
• Last updated: March 15, 2018
• Start date: July 20, 2017
• Est. completion date: September 1, 2021

Study information

• Verified date: May 2017
• Source: Zhujiang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Endoscopic retrograde cholangiopancreatography (ERCP) is commonly performed to remove bile duct stones.Endoscopic sphincterotomy (EST), endoscopic papillary balloon dilation (EPBD), and endoscopic sphincterotomy plus balloon dilation (sEST+EPBD) are 3 methods used to enlarge the papillary orifice, but their efficacy and safety remains controversial. This study aimed to compare these methods for treating common bile duct (CBD) stones.

Description:

Investigators first divided the patients with different sizes of common bile duct stones into two groups. The bile duct stone diameter of group A is less than 1.0cm while group B is more than 1.0cm and less than 1.5cm. Each group compared Endoscopic sphincterotomy (EST), endoscopic papillary balloon dilation (EPBD), and endoscopic sphincterotomy plus balloon dilation (sEST+EPBD) in ERCP. Through the postoperative comparison of relevant inspection test indicators, the recovery of patients, whether the occurrence of complications, including infection,bleeding,pancreatitis,perforation , and 1 year stone recurrence rate,Investigators assess the advantages and disadvantages in three different strategies in different sizes of common bile duct stones , and finally get a relatively objective evaluation to guide our daily ERCP work on the choice of duodenal papillary sphincter treatment strategy.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 450
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 20-80 years old

• CT or MRCP diagnose the patients with Common bile duct stones

• The diameter of the stone is less than or equal to 1.5cm

• Patients with the indications for ERCP

• Patients and their families agree to participate in the trial

Exclusion Criteria:

• Stones are too large (> 1.5cm)

• A history of gastrointestinal surgery

• ERCP and EST or EPBD surgery history

• Patients generally poor, total bilirubin> 200umol / L or PT time extension> 3s

• Patients with mental illness or other serious heart and lung disease

Related Conditions & MeSH terms

• ERCP

Intervention

Device:
• Erbao electric knife
Erbao electric knife is used to cut the Duodenal sphincter
• Three-cavity incision knife
Three-cavity incision knife is used to cut the Duodenal sphincter
• Columnar expansion balloon
Columnar expansion balloon is used to expand the the Duodenal sphincter

Locations

Country	Name	City	State
China	Zhujiang Hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Zhujiang Hospital	Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of composite events of infection, hemorrhage, perforation, pancreatitis	Investigators comprehensively assess whether the hemorrhage, perforation, pancreatitis and other complications of retrograde cholangiopancreatography (ERCP) happen or not by clinical sympton and blood index 1 day after the ERCP. The blood index includes CRP, amylase,lipase,leukocyte,red blood cell,hemoglobin.Besides,CT will be done if necessary.Finally investigators use statistical method to analyse the incidence of composite events of infection, hemorrhage, perforation, pancreatitis.	3 and 24 hours after the ERCP
Secondary	Recurrence rate of bile duct stones	One year after the ERCP,the participants will have a CT scan to find out whether the bile duct stones recur again.	1 year after the ERCP.